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Test reliability and comparability of paper and Chinese electronic version of the western Ontario and McMaster University osteoarthritis index: protocol for a randomised controlled clinical trial

BMJ (recent)

Introduction
The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.

Methods and analysis
A total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.

Ethics and dissemination
The protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number
ChiCTR2100050914.

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Novembre 2022

Abstract 12737: Baseline Carotid Sinus Massage in the Supine Position Predicts Outcome of Head Up Tilt Table Testing: Potential for Abbreviating the Tilt Table Test Protocol

Circulation

Circulation, Volume 146, Issue Suppl_1, Page A12737-A12737, November 8, 2022. Introduction:Carotid sinus massage (CSM) has been used to evaluate carotid sinus hypersensitivity. Its role in evaluating a vasodepressor response has not been well studied. CSM can also result in a vasodepressor response in the absence of significant bradycardia. Its role in predicting the subsequent outcome of head-up tilt testing (HUT) is not well defined.Hypothesis:A vasodepressor response elicited with baseline carotid sinus massage (CSM) may predict the subsequent outcome of HUT.Methods:In this prospective study Consecutive patients with a history suggestive of a reflex neurocardiogenic etiology underwent HUT. Patients underwent HUT testing using a standard protocol, including baseline CSM in the supine posture followed by HUT testing at 60 degrees for 30 minutes. If negative, a repeat of CSM was performed in the upright posture. Then, isoproterenol was infused in incremental dose 1 to 3 mcg/minute.Results:25 patients (20 females and 5 males) with a mean age of 52.87±6.77 years underwent HUT. 5 out of 25 (20%) patients had a positive tilt result for a vasodepressor response. 4 of these 5 patients had a significant vasodepressor response (symptomatic hypotension BP drop less than 30 mmHg) without significant bradycardia (HR less than 50 BPM) during CSM in the supine posture. Of these patients, 3 patients became positive during HUT and 1 patient became positive during isoproterenol infusion. The positive predictive value was 0.8. Sensitivity was 67%. 20 out of 25 (80%) patients had a negative tilt result for a vasodepressor response despite protocol completion. 18 of these 20 patients had no drop in BP during CSM and no significant bradycardia. The negative predictive value was 0.9. The specificity was 94.74%. 2 of these patients had a negative response on CSM but a borderline response at HUT with borderline symptoms with the isoproterenol. These 2 had a transient drop in BP when CSM was repeated at the end of 30 minutes during the head-up position.Conclusions:In this population of patients, a negative CSM in the supine posture predicted a subsequent negative Tilt test. Baseline CSM can be performed at the bedside and may obviate the need for full tilt table testing even for patients with a clinical diagnosis of reflex syncope (vasodepressor).

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Ottobre 2022
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